Does Lilly have the most powerful supercomputer in the pharmaceutical industry?
Eli Lilly Chairman and CEO David A. Ricks talks about Lilly’s pharmaceutical industry’s most powerful supercomputer.
Pharmaceutical giant Eli Lilly and Co. has given an unidentified 79-year-old man exclusive access to the company’s experimental obesity and diabetes drug, according to a report from life science media organization STAT.
The practice was so unusual that the magazine asked the White House whether President Donald Trump was the only person to receive the coveted drug, according to clinicians, bioethics experts and current and former government health officials interviewed by STAT. Trump was 79 years old when the drug was requested (in April) and previously told the New York Times that he “probably should” take the GLP-1 drug.
However, after not directly answering STAT’s questions, the White House denied reports that the request for special access to the drug was for the president.
An Eli Lilly spokeswoman said the company does not respond to questions about individual applications.
“In the rare event that an individual is unable to participate in a clinical trial and treatment options are exhausted, Lilly may work with the referring physician to provide an investigational drug,” said Michael Jamison, Lilly’s communications director for litigation and special products. “We make these decisions in accordance with all applicable regulations.”
Here’s what we know:
What is medicine?
Eli Lilly’s new drug, letratortide, is a triple hormone receptor agonist currently in Phase 3 clinical trials to treat a variety of conditions, including obesity, type 2 diabetes, and obstructive sleep apnea.
In other words, it’s a more powerful version of GLP-1 drugs like Wegovy and Ozempic, which are expected to revolutionize weight loss and create a $100 billion market by 2030.
Weight loss results from the latest phase of clinical trials of letratortide show that the drug has a level of efficacy comparable to bariatric surgery. This breakthrough led to the creation of a black market for the drug, which has not yet been approved by the Food and Drug Administration.
How did the individual gain access?
The drug was requested through the FDA’s “compassionate use” program, a process that makes drugs available to patients with life-threatening conditions before they reach the market, STAT said.
STAT reported that the drug was requested by a senior clinician at the National Institutes of Health for a patient with refractory obesity who has obstructive sleep apnea and pulmonary hypertension.
Experts STAT spoke to said it was unusual for Eli Lilly to give just one person exclusive access to an obesity drug that could help millions. STAT’s report also suggested that the individuals who received the drug were well-connected, especially since one public post about the drug’s compassionate use program did not provide information about which patients or conditions were eligible.
Spokespeople for the White House and the Department of Health and Human Services did not respond to STAT’s questions about the patient’s identity, but the publication pointed to Trump’s most recent medical exam in May, which said Trump was in “excellent health.”
President Trump has expressed interest in weight loss drugs in the past, but told the New York Times in January that he had never taken them. But sources who spoke to STAT said the unnamed patient had been treated with another Lilly obesity drug for a year.
Speculation surrounding President Trump and the mysterious drug application stems from the president’s close relationship with Eli Lilly CEO David Ricks.
For example, Trump dined with Ricks at Mar-a-Lago and praised his talents as a CEO. The president bought $680,000 in Lilly stock earlier this year, and his administration has promoted initiatives that benefit the company.
How common is it to get exclusive access?
According to Lilly’s website, Lilly offers three primary avenues for patients who urgently need access to investigational medicines: clinical trial participation, expanded cohort access, and expanded individual patient access.
Lilly provides expanded access (another term for compassionate use) under certain conditions.
- The person has a serious or life-threatening illness and there is no alternative treatment.
- That person cannot participate in clinical trials.
- There is evidence that taking experimental drugs provides benefits to a person that outweigh the risks.
- The requested drug is currently undergoing human testing.
- The provision of medicines does not interfere with clinical trials.
Once a company has a good understanding of how a new drug works, expanded access may be offered to certain groups of people. But access by individuals is even rarer, according to Lilly’s website.
“In the absence of a cohort expanded access program, and in rare cases where local regulations permit and our expanded access criteria are met, Lilly may decide to provide individual patients with access to investigational medicines at the request of their physicians,” the website’s expanded use policy states.
Contact political news reporter Marissa Meador at mmeador@indystar.com or find her at X (@marissa_meador).
